The sale of weight loss drug sibutramine is set to be suspended across the European Union because of an increased risk of cardiovascular events, following a decision by its drug regulator.
The European Medicines Agency (EMA) announced yesterday that it had recommended that doctors no longer prescribed and pharmacists no longer dispensed the drug – marketed in Australia as Ectiva or Reductil – and will now take the recommendation to the European Commission for formal adoption.
Earlier this week, the Therapeutic Goods Administration (TGA) rejected claims that it had also called on doctors to stop prescribing sibutramine and said it was still in the process of conducting a review.
The move in Europe came after an EMA committee analysed data from a study, dubbed SCOUT and released in November last year, that found more cardiovascular events in sibutramine patients than those taking a placebo.
While most of the 10,000 people in the SCOUT study may not have been eligible for treatment with sibutramine because of its contraindication for underlying cardiovascular disease, EMA said the data was relevant because overweight people were likely to have a higher risk of cardiovascular events anyway.
"The committee also noted that the data from available studies show that the weight loss achieved with sibutramine is modest and may not be maintained after stopping," EMA said in a statement.
"The [committee] was therefore of the opinion that the benefit of sibutramine as a weight-loss aid do not outweigh the cardiovascular risks."
Jennifer Stevenson, spokeswoman for sibutramine maker Abbott, said the company would comply with EMA but would continue selling it outside the EU.
"Abbott's evaluation of the SCOUT study does not change its assessment that sibutramine has a positive benefit/risk profile when used appropriately in the approved patient population," Ms Stevenson said.
"We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine."